U.S., June 15 -- ClinicalTrials.gov registry received information related to the study (NCT03182842) titled 'FreeStyle Libre FGM During Summer Camp for Children With Type 1 Diabetes' on June 7.
Brief Summary: A randomized, double-blinded, single center, parallel design pediatric study, on 45 subjects with type 1 diabetes (T1D), aged six to 15 (inclusive) years, measuring sensor time in glucose values within range 3.9 - 10 mmol/l (70 - 180 mg/dl) achieved using the FreeStyle Libre Flash Glucose Monitoring System (FGM - intervention, Abbott Diabetes Care, California, USA) versus Self-Monitoring Blood Glucose (SMBG - control).
Study duration will be two weeks per subject and two weeks overall, it will take place at youth summer camp for children with T1D. Main inclusion criteria include age of six to 15 (inclusive) years, clinical diagnosis of T1D for at least six months, at least three months of current use of insulin pump therapy, HbA1c between 6.3 and 10 % (both inclusive), no other chronic medical conditions (beside treated hypothyroidism and celiac disease) and no current medications (other than insulin) (detailed list of inclusion and exclusion criteria list can be found at section 6).
The objectives of this clinical investigation is:
1. to evaluate the efficacy of glucose control using the FreeStyle Libre FGM in children with T1D during two weeks of summer camp.
Study Start Date:
Study Type: Interventional
Condition: Type 1 Diabetes Mellitus
Hypoglycemia
Hyperglycemia
Intervention: Device: FreeStyle Libre FGM
Insulin dosing based on FreeStyle Libre FGM system that is indicated for measuring interstitial fluid glucose levels in people (age 4 and older) with diabetes mellitus.
Other Name: Intervention - Sensor ON
Device: SMBG - Blinded Sensor
Insulin dosing based on SMBG
Other Name: Control
Recruitment Status: Recruiting
Sponsor: University of Ljubljana, Faculty of Medicine
Information provided by (Responsible Party): University of Ljubljana, Faculty of Medicine
Published by HT Digital Content Services with permission from Health Daily Digest.